Bayer is rushing to appease the FDA. It has suspended two unnamed employees and retained a high-profile Washington lawyer to launch an internal probe into why preliminary data about Trasylol, a protease inhibitor, was not submitted to the agency before a public advisory meeting in late September.

Bayer now says it was a mistake to not share retrospectively gathered data with the FDA. “This data was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology,” the German company said late in September.

Now, in an October news statement,  Bayer announced it suspended two key employees. It also retained Fred F. Fielding, a former aide to President Ronald Reagan, to investigate who buried the Trasylol data and how to prevent that from happening again. Bayer vows to release Fielding’s report when it’s done. 

Here’s the back story. “This data was not shared immediately with the agency because it was preliminary in nature and raised significant questions on the study population, outcomes and methodology,” the German company said in a statement late in September.

In a September 21, 2006 advisory meeting, Bayer said nothing about an additional safety study of Trasylol, a protease inhibitor. Five days later, Bayer said, more or less, “oops.”

Here’s a new quote from the company’s top lawyer, Roland Hartwig: “Bayer has acknowledged and regrets the error it made in not sharing with the FDA information regarding this study prior to the September 21 Advisory Committee Meeting on Trasylol. Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals. These individuals have been suspended. Bayer will cooperate fully with Mr. Fielding’s investigation. We also anticipate that this independent investigation could result in a specific corrective action plan,”

It’s not clear whether the employees are based in the U.S., or even if they are actually Bayer employees or working for an unidentified contract research organization (CRO). It is clear the FDA wants to avoid creating the impression that its advisory committees lack the facts to make sound decisions. The committees are under enough fire for consulting ties and research grants from the same companies they’re making decisions about. Alas, it’s not clear that those without any known conflicts of interest have sufficient domain expertise to take on the work.

The FDA, meanwhile, is sufficiently worried that it has an advisory. “Physicians who use Trasylol should carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report observed adverse event information to Bayer Pharmaceuticals, the drug manufacturer, or to the FDA MedWatch program,” the agency said.

The FDA statement lays out the saga in stark terms: “The new study was done for Bayer by a contract research organization.  Existing hospital data from 67,000 records of patients undergoing coronary artery bypass graft surgery were examined.  30,000 of the patients were treated with Trayslol and 37,000 were treated with alternate products.  Using complex epidemiological and statistical methods, the report suggested that patients receiving Trasylol were at increased risk for death, kidney failure, congestive heart failure and stroke.”

Bayer should shoot an email over to one of the bigger medical journals. We can’t imagine they’d turn down any study with those sorts of numbers. It might sting at first. Over the long haul, that sort of candor would begin to turn the industry’s reputational deficit around.

We feel a bit for the two Bayer employees. Whether two employees out of the 34,000 employed at Bayer Healthcare are truly responsible for setting the company’s policy is open to debate. Even so, the Bayer response is rapid, definitive and, by appearances, more conciliatory toward the FDA than what U.S. companies typically do under such circumstances. On the web, meanwhile, personal injury lawyers are scrambling to find (or create) patients harmed by Trasylol. It feels like a familiar circus is coming to town again.